# K131325: Quattro GL Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Cayenne Medical, Inc.
- Decided: Aug 16, 2013 after 100 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K990088 (1999). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071586: Bioraptor 2.3 PK Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 3.
- K112960: Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe Suture, Cayenne Medical, Inc. (2012) Summary page 3.
- K040472: Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture, Teleflex Medical (2004) Summary page 3.
- K070673: Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture, Teleflexmedical, Inc. (2007) Summary page 3.
- K100506: Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Model:X-5000FFK, X-5001FFK, X-5002FFK, Teleflex Medical (2010) Summary page 3.
- K092533: Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures, Beere Precision Medical Instruments, Kmedic, Telef (2009) Summary page 3.

## Indications for use
The Cayenne Medical, Inc. Quattroo GL Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Hip - Hip capsule repair o Acetabular labrum reattachment Shoulder - Capsular stabilization o Bankart repair o Anterior shoulder instability o SLAP lesion repairs o Capsular shift or capsulolabral reconstructions - Acromnioclavicular separation repairs - Deltoid repairs - Rotator cuff repairs - Biceps tenodesis Elbow, Wrist, and Hand - Biceps tendon reattachment - Ulnar or radial collateral ligament reconstruction - Lateral epicondylitis repair Knee - Extra-capsular repairs o Medial collateral ligament o Lateral collateral ligament Posterior oblique ligament - Patellar realignment and tendon repairs o Vastus medials obliquous advancement - illiotibial band tenodesis Foot and Ankle - H-aliux valgus repairs - Medial or Lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions - Midifoot reconstructions - Metatarsal ligament/tendlon rcpairs/reconstructions - Bunionectomy

Source page: https://510kreport.com/device/K131325
Methodology: https://510kreport.com/methodology